Phase 3 N=87 Treatment

Brain Imaging and Treatment Studies of the Night Eating Syndrome

Night Eating Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01401595 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Change in Symptoms of NES — 46.1; 11.8; 17.4; NA percentage of calories after dinner

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: escitalopram oxalate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Symptoms of NES	46.1; 11.8; 17.4; NA	—
SECONDARY Nocturnal Ingestions	5.8; 0.0; 1.2; NA	—
SECONDARY Night Eating Symptoms	30.2; NA; 15.2; NA	—

Summary

The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.

Eligibility Criteria

Inclusion Criteria

men and women suffering from NES
ages 18 to 70 years
BMI greater than 18.5 kg/m2

Exclusion Criteria

Children or adolescents <18 years
persons older than 70
patients with diabetes mellitus
thyroid disease and other endocrine and metabolic disorders
use within the past month of any psychotropic medication, oral steroids, diuretics or hypnotics
current anorexia nervosa or bulimia nervosa
participation in an organized weight reduction program
use of antiobesity medication
an occupation that involves night shifts or other unusual time requirements -Major Depressive Disorder (judged severe)
Bipolar Disorder
suicidal risk
current or past psychosis
substance use or abuse disorder within the past 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01401595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.